The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia.
According to the Swiss company, the wearable’s optical sensors can capture continuous blood pressure readings similar to the traditional inflated cuff with monthly calibrations, and they have demonstrated accuracy across a variety of skin tones—as well as while the user is sitting, standing or lying down.
The system previously obtained a CE Mark approval in Europe, and Aktiia said its newly 510(k)-cleared product will reach the U.S. sometime in 2026. The Hilo bracelet has also been given go-aheads in Canada, Australia and Saudi Arabia, and more than 120,000 have already been sold, the company said.
“This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” Aktiia’s co-founder and chief technology officer, Josep Sola, said in a statement. “With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”
Earlier this year, the company put forward a clinical study conducted with the Mass General Brigham health system that included patients with uncontrolled hypertension and the remote management of their medications. Compared to daily measurements with an inflatable cuff, 91% said they preferred the smartphone-connected Hilo monitor, and researchers said the system could provide a platform for easy out-of-office blood pressure readings.
“This milestone is the result of more than seven years of relentless scientific, clinical, and engineering effort,” said Aktiia co-founder Mattia Bertschi. “What began as a research vision in the Swiss Research Institute CSEM twenty years ago has now become the world’s first cuffless, FDA-cleared, over-the-counter solution for blood pressure—and we’re just getting started.”
The agency’s green light comes shortly after the company collected $42 million through a venture capital fundraising in early May. The series B round (PDF) was co-led by Earlybird Health and Wellington Partners, and included backing from Kfund, naturalX Health Ventures, redalpine, Khosla Ventures, Molten Ventures, Translink Capital and Verve Ventures. At that time, the company also adopted the Hilo moniker in some markets.
“Aktiia’s FDA clearance represents a breakthrough moment for medical-grade wearables,” said Earlybird principal Christoph Massner, who also serves as Aktiia’s board director. “We backed the team because they combined bold vision with scientific rigor, and today they’ve delivered what no one else could. The Hilo Band is poised to lead a global transformation in how we understand and manage cardiovascular health at scale.”